Negative Beta Glucan in ICU Patients

Candidemia Clinical Trial

Official title:

A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734525
• Other study ID #: Early Therapy
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2019
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.

Therefore, the objectives of this study are:

1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;

2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Description:

Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.

Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.

If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In the ICU for >2 days AND

• Systemic antibiotics on days 1-3 of ICU OR

• Central venous catheter on days 1-3 of ICU

• AND at least 2 of:

• Total parenteral nutrition on days 1-3 of ICU

• Any dialysis on days 1-3 of ICU

• Major surgery in the 7 days before admission in the ICU

• Pancreatitis in the 7 days before admission in the ICU

• Use of corticosteroids for at least 3 days in the 7 days before admission

• Use of other immunosuppressive agents in the 7 days before admission in the ICU

• In addition, the patient must have at least one of the following:

• Fever (axillary temperature >37.5 oC)

• Hypothermia (axillary temperature <35 oC)

• Hypotension

• Unexplained acidosis

• Unexplained elevation in C-reactive protein

Exclusion Criteria:

• Antifungal for >3 days

• Allergy to an echinocandin

Related Conditions & MeSH terms

• Candidemia

Intervention

Drug:
• Anidulafungin
Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin	The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin	30 days